Submission date
13/02/2008
Registration date
26/02/2008
Last edited
06/08/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Retrospectively registered
? Protocol not yet added
? SAP not yet added
Results added
? Raw data not yet added
Study completed

Plain English Summary

Not provided at time of registration

Study website

Contact information

Type

Scientific

Contact name

Dr John Marsden

ORCID ID

Contact details

Institute of Psychiatry
King's College London
PO Box 048
4 Windsor Walk
London
SE5 8AF
United Kingdom
-
J.Marsden@iop.kcl.ac.uk

Additional identifiers

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

V#1, 10/01/06

Study information

Scientific title

An evaluation of a brief assessment-led intervention with young non-injecting drug users

Acronym

Study hypothesis

That participants receiving a brief assessment-led intervention would at 3 months follow-up have a lower mean frequency of cannabis use, cocaine use, crack cocaine use and MDMA (3,4 methylenedioxymethamphetamine; Ecstasy) use combined than delayed assessment control participants

Ethics approval(s)

King's College London, 17/10/2005, ref: 05/Q0706/219

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Not specified

Study type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Substance misuse

Intervention

Experimental: A brief assessment-led intervention
a. Drugs and Lifestyle Assessment
b. Manual guided 30 minute feedback interview
Control 1: Assessment only
Control 2: Delayed assessment

Intervention type

Behavioural

Primary outcome measure

Combined frequency of cocaine powder use, crack cocaine use, MDMA use and cannabis use, assessed at baseline and 90 days

Secondary outcome measures

The following were assessed at baseline and 90 days:
1. Typical intensity of cannabis use, cocaine use, crack cocaine use and MDMA use at 90 days
2. Drug dependency: Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) Personality Disorders (Structured Clinical Interview for DSM-IV Axis II Personality Disorders; SCID-II)
3. Alcohol frequency and intensity
4. Hazardous drinking: The Alcohol Use Disorders Identification Test (AUDIT)
5. General health: EQ-5D A multi-dimensional Quality of Health Instrument (EurQol)
6. Psychological health: General Health Questionnaire (GHQ 12)
7. Engagement with health and social services

Overall study start date

01/10/2005

Overall study end date

29/01/2008

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. 16 to 28 years old
2. Using either cannabis, cocaine powder, crack cocaine, or MDMA on four days in previous month
3. Able speak and comprehend English
4. Written consent

Participant type(s)

Other

Age group

Adult

Sex

Both

Target number of participants

255

Total final enrolment

342

Participant exclusion criteria

1. In contact with a drug/alcohol treatment agency in previous 12 months
2. Used opiates more than 30 days in the previous 90 days or in the previous 48 hours before interview
3. Injected more than once in the last 12 months and no more than ten times lifetime
4. Receiving specialist treatment for a mental health problem
5. Participated in a similar research study in the previous 12 months

Recruitment start date

01/10/2005

Recruitment end date

29/01/2008

Locations

Countries of recruitment

England, United Kingdom

Study participating centre

Institute of Psychiatry
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

Institute of Psychiatry
Kings College London
4 Windsor Walk
London
SE5 8AF
England
United Kingdom
-
gill.lambert@iop.kcl.ac.uk

Sponsor type

University/education

Website

http://www.iop.kcl.ac.uk

ROR

https://ror.org/0220mzb33

Funders

Funder type

Government

Funder name

Department of Health of England & Wales, Drug Misuse Research Initiative (Phase 2) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2006 06/08/2020 Yes No

Additional files

Editorial Notes

06/08/2020: The following changes were made to the trial record: 1. Publication reference added. 2. The total final enrolment was added. 08/06/2017: No publications found, verifying study status with principal investigator.